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Caphosol® Versus State-of-the-art Mouthcare in Patients With Allogeneic Stem Cell Transplantation: a Randomized Controlled Study About the Efficacy of the Mouth Rinse Caphosol®

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ClinicalTrials.gov Identifier: NCT01758562
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Randomized controlled study about the efficacy of the mouth rinse Caphosol in patients with allogeneic stem cell transplantation. 85% of the patients receive a severe oral mucositis due to their treatment.

70 patients will be randomized in the intervention (Caphosol) or in the standard (state-of-the-art) group. Primary endpoint is the duration of the mucositis, secondary endpoints are the occurence of oral mucositis measured with the WHO-scale and the occurence of pain measured with the NRS-scale (Numeric Rating Scale).

  • Trial with medical device

Condition or disease Intervention/treatment
Allogeneic Stem Cell Transplantation Device: Caphosol

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : January 2013
Primary Completion Date : August 2014
Study Completion Date : August 2014
Arms and Interventions

Arm Intervention/treatment
No Intervention: State-of-the-art mouth care
Active Comparator: Mouth rinse Caphosol
Mouth rinse,aqueous solution. Caphosol is a preparation comprising two separately packaged aqueous solutions, a phosphate solution and a calcium solution, which, when both solutions are combined in equal volumes, forms a solution supersaturated with respect to both calcium and phosphate ions.
Device: Caphosol


Outcome Measures

Primary Outcome Measures :
  1. Duration of oral mucositis [ Time Frame: 20-30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Allogeneic stem cell transplantation
  • Male and female patients age 18-80
  • Signed informed consent after information

Exclusion criteria:

  • Contra-indications due to ethical reasons
  • Unable to read or write
  • Unable to speak or understand the german language
  • Low-salt diet
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758562


Locations
Switzerland
University Hospital Zurich, Centre of Clinical Nursing Science
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Rebecca Spirig, Prof MD University Hospital Zurich, Centre of Clinical Nursing Science
More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01758562     History of Changes
Other Study ID Numbers: Capo
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014